Implementing National HIV/AIDS Strategy 2015 Treatment Targets Is Cost-effective and Would Save Lives: What Other Evidence Do We Need?

In response to persistently elevated human immunodeficiency virus (HIV) incidence in the United States, the Obama administration released the first National HIV/ AIDS Strategy (NHAS) in 2010 to concentrate national attention on ending the domestic epidemic and coordinate the nation’s response. The NHAS incorporated measurable objectives to help repair defects in the continuum of HIV care that contributed to high HIV infection rate

Preventing HIV among women - A step forward, but much farther to go

The 900,000 new HIV infections among women globally in 2015 attest to the urgent need for the dissemination of effective new HIV-prevention products for women. Most women are infected with HIV by means of sexual activity with men. Therefore, the treatment of persons with HIV is one of the most effective strategies for the prevention of new cases of HIV infection among women. However, few countries have attained the level of antiretroviral coverage in the population that is required to eliminate transmission, and women need prevention methods that they can control themselves. Long-acting products that decrease the burden of adherence are especially needed. This issue of the Journal reports the results of two trials that move HIV prevention a step closer

Syndemic theory, structural violence and HIV among African-Americans

Purpose of reviewThis paper will review recent use of syndemic frameworks in HIV research among African-Americans.Recent findingsResearchers have used syndemic theory in diverse African-American study populations, including MSM, cis-women, trans-women, heterosexual men and adolescents. These studies have evaluated the associations between syndemic conditions and a variety of outcomes, such as sexual behaviours, HIV and other sexually transmitted infections, HIV testing, adherence to antiretroviral therapy, HIV suppression and preexposure prophylaxis use. The most frequently evaluated syndemic conditions have been depression, substance use and personal experience of abuse or violence; a few studies have included experience of incarceration and unstable housing.SummaryThese studies have yielded valuable insights into links between HIV-related outcomes and mental health, experience of violence and abuse, and substance use. But a key feature - and major utility - of the syndemics framework is its potential for examining not only synergistic individual-level risk factors but also the interactions with economic, political and social systems that influence these individual-level factors and thereby shape the HIV epidemic among African-Americans. Research that takes these systems into account is needed to inform policy changes that can help end the HIV epidemic in this population

Racial justice and HIV in the United States: now is the time

Abundant evidence demonstrates the effects of racism in producing and maintaining the nation’s persistent, dramatic racial inequities in rates of HIV infection, cardiovascular disease, cancer and death. Racism has defined the lives of Black people in America for centuries. In recent years, however, instant dissemination of cellphone videos has put the almost routine extrajudicial executions of Black Americans on vivid display. This past spring, the video of George Floyd’s murder by police galvanized the nation into beginning to recognize the impact of racism on Black Americans. Protests for racial justice occurred in more than 2500 US cities and 40% of the nation’s counties, with participation of an estimated 15 to 26 million people, making these recent protests possibly the largest in US history

US Black Women and Human Immunodeficiency Virus Prevention: Time for New Approaches to Clinical Trials

Black women bear the highest burden of human immunodeficiency virus (HIV) infection among US women. Tenofovir/emtricitabine HIV prevention trials among women in Africa have yielded varying results. Ideally, a randomized controlled trial (RCT) among US women would provide data for guidelines for US women's HIV preexposure prophylaxis use. However, even among US black women at high risk for HIV infection, sample size requirements for an RCT with HIV incidence as its outcome are prohibitively high. We propose to circumvent this large sample size requirement by evaluating relationships between HIV incidence and drug concentrations measured among participants in traditional phase 3 trials in high-incidence settings and then applying these observations to drug concentrations measured among at-risk individuals in lower-incidence settings, such as US black women. This strategy could strengthen the evidence base to enable black women to fully benefit from prevention research advances and decrease racial disparities in HIV rates

HIV in the USA: priorities for the new administration

President-elect Joe Biden and Vice President-elect Kamala Harris were elected at an extraordinary moment in US history, with the COVID-19 pandemic surging, severe social and economic strain, and a reckoning over racial injustice. COVID-19 has revealed the structural weaknesses of the US health-care system and our millions of uninsured and underinsured people. Health disparities evident in the US HIV epidemic were replicated by COVID-19 with startling speed and severity, disproportionately affecting Black, Latinx, and Indigenous communities, the poor, the unstably housed, the imprisoned, and those at the social margins. Responding to the COVID-19 pandemic is an urgent priority for the new administration. Responding to the HIV epidemic in the USA should be as well

Computerized Adjudication of Coronary Heart Disease Events Using the Electronic Medical Record in HIV Clinical Research: Possibilities and Challenges Ahead

This pilot study assessed feasibility of computer-assisted electronic medical record (EMR) abstraction to ascertain coronary heart disease (CHD) event hospitalizations. We included a sample of 87 hospitalization records from participants the University of North Carolina (UNC) site of the Women's Interagency HIV Study (WIHS) and UNC Center for AIDS Research (CFAR) HIV Clinical Cohort who were hospitalized within UNC Healthcare System from July 2004 to July 2015. We compared a computer algorithm utilizing diagnosis/procedure codes, medications, and cardiac enzyme levels to adjudicate CHD events [myocardial infarction (MI)/coronary revascularization] from the EMR to standardized manual chart adjudication. Of 87 hospitalizations, 42 were classified as definite, 25 probable, and 20 non-CHD events by manual chart adjudication. A computer algorithm requiring presence of ≥1 CHD-related International Classification of Diseases, 9th Revision (ICD-9)/Current Procedural Terminology (CPT) code correctly identified 24 of 42 definite (57%), 29 of 67 probable/definite CHD (43%), and 95% of non-CHD events; additionally requiring clinically defined cardiac enzyme levels or administration of MI-related medications correctly identified 55%, 42%, and 95% of such events, respectively. Requiring any one of the ICD-9/CPT or cardiac enzyme criteria correctly identified 98% of definite, 97% of probable/definite CHD, and 85% of non-CHD events. Challenges included difficulty matching hospitalization dates, incomplete diagnosis code data, and multiple field names/locations of laboratory/medication data. Computer algorithms comprising only ICD-9/CPT codes failed to identify a sizable proportion of CHD events. Using a less restrictive algorithm yielded fewer missed events but increased the false-positive rate. Despite potential benefits of EMR-based research, there remain several challenges to fully computerized adjudication of CHD events

Estimating Human Immunodeficiency Virus (HIV) Prevention Effects in Low-incidence Settings

Background: Randomized controlled trials (RCTs) for determining efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) infection have not been conducted among US women because their lower HIV incidence requires impractically large studies. Results from higher-incidence settings, like Sub-Saharan Africa, may not apply to US women owing to differences in age, sexual behavior, coinfections, and adherence. Methods: We propose a novel strategy for evaluating PrEP efficacy in the United States using data from both settings to obtain four parameters: (1) intention-to-treat (ITT) and (2) per-protocol effects in the higher-incidence setting, (3) per-protocol effect generalized to the lower-incidence setting, and (4) back-calculated ITT effect using adherence data from the lower-incidence setting. To illustrate, we simulated two RCTs comparing PrEP against placebo: one in 4000 African women and another in 500 US women. We estimated all parameters using g-computation and report risk ratios averaged over 2000 simulations, alongside the 2.5th and 97.5th percentiles of the simulation results. Results: Twelve months after randomization, the African ITT and per-protocol risk ratios were 0.65 (0.47, 0.88) and 0.20 (0.08, 0.34), respectively. The US ITT and per-protocol risk ratios were 0.42 (0.20, 0.62) and 0.17 (0.03, 0.38), respectively. These results matched well the simulated true effects. Conclusions: Our simple demonstration informs the design of future studies seeking to estimate the effectiveness of a treatment (like PrEP) in lower-incidence settings where a traditional RCT would not be feasible. See video abstract at, http://links.lww.com/EDE/B506

The Relationship Between Economic Deprivation, Housing Instability and Transactional Sex Among Women in North Carolina (HPTN 064)

Transactional sex is associated with socioeconomic disadvantage and HIV risk but few studies in the United States (US) have examined both individual and area-level predictors of transactional sex or distinguished transactional sex from sex work. We combined data from HIV Prevention Trials Network 064 study and the US Census to estimate prevalence ratios (PR) for the relationship between census-level and individual measures of economic deprivation and housing instability on transactional sex in 417 women in North Carolina. Increased transactional sex was associated with food insecurity (PR 1.86; 95%; CI 1.57, 2.19), housing instability (PR 1.33; 95% CI 1.11, 1.59), substance abuse (PR 1.90; 95% CI 1.64, 2.19) and partner incarceration (PR 1.32; 95% CI 1.09, 1.61). Census-level indicators were not associated with transactional sex, adjusted for individual-level covariates. Interventions should support housing stability and financial opportunities among southern African American women to reduce HIV risk, particularly among women with incarcerated partners

Ending HIV in the USA: integrating social determinants of health – Authors' reply

In their response to our call to action in the Lancet Series on HIV in the USA, Courtenay Sprague and Sara E Simon argue that biomedical solutions alone have failed, and will continue to fail, to control the HIV epidemic in the USA and that policy must include efforts to address the social determinants of health. We concur, and believe that the Series on HIV in the USA highlights these important concerns